510(k) Report

Devices descending from K071922

1,221 later devices reach Interplate Interbody Fusion Device, Models C, CGC, L and LGC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+5K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+5K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+5K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+5K193258ProLift Expandable SystemLife Spine, Inc.20203—
+5K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+5K193174Keos Lumbar IBFDKeos20190—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+5K190721LongBow TiLife Spine, Inc.20190—
+5K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+5K1803473d CageFims Co., Ltd.20190—
+5K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+5K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+5K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+5K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K183243Velofix TLIF CageU&I Corporation20190—
+5K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+5K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K191263Idys ALIF TiVacClariance, Sas20190—
+5K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+5K183092Kuros TLIF CageKuros Biosciences B.V20190—
+5K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+5K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+5K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+5K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+5K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+5K182477Cervical SpacerAdditive Implants, LLC201915—
+5K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+5K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+5K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+5K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+5K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+5K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K181829Velofix TLIF CageU&I Corporation20181—
+5K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+5K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+5K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+5K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+5K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+5K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+5K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+5K171312FortiCore®Nanovis, LLC20183—
+5K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+5K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+5K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+5K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+5K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+5K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+5K172424Velofix™ SA Cervical CageU&I Corporation201751
+5K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+5K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+5K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+5K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+5K172065Scarlet AC-TSpineart20172—
+5K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K171704CAPRI Corpectomy Cage SystemK2m201710—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+5K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+5K171425Concorde LiftMedos International SARL201782
+5K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—